For those facing the challenging diagnosis of ALK-positive lung cancer, brain metastases often pose a serious concern. Research reveals that up to 40% of these patients have brain metastases right from the start. This sets the stage for a critical question in treatment planning: Is it better to tackle these brain metastases with spot radiation, or stereotactic radiosurgery (SRS)
Read MoreClinical trials are the gold standard for evaluating new treatments in medicine. They offer a structured approach, where patient groups are carefully selected, treatments are administered, and results are meticulously followed over time. This controlled environment allows for a deep understanding of how treatments perform in specific patient populations, free from the confounding factors that might skew results.
Read MoreThis trial is for patients with Stage 4 ALK positive NSCLC that have progressed on an earlier generation ALK TKI AND lorlatinib, and on any number of other standard-of-care or trial treatments. The trial drug is gilteritinib (aka Xospata), which was approved by the FDA in 2018 for a type of leukemia, but has been shown to have activity against ALK NSCLC in patient-derived models (mice with transplanted human cancer).
Read MoreCAMBRIDGE, Mass., May 16, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to NVL-655 for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who have been previously treated with two or more ALK tyrosine kinase inhibitors (TKIs).
Read MoreIn the ever-evolving arena of ALK-positive cancer therapies, clinical trials offer patients not only cutting-edge interventions but also a chance to contribute to the advancement of ALK cancer treatment. In examining international ALK cancer trials, we uncover both challenges and opportunities for those seeking innovative treatments beyond conventional options.
Read MoreI started on the Phase II NVL-655 trial on March 1st, 2024, at UC Davis’s Sacramento campus, a seventy-five-mile ride from my house. I had pre-registered with Dr. Jonathan Riess’s trial coordinator in December, sending records from my oncologist electronically, and answering a lot of questions. They wanted a record of my initial cancer, and details on the mutations that came up with various progressions, along with all the dates. The current mutational profile was most important to the doctor for qualification to participate. My local oncologist knew Dr. Riess personally, which helped, I think, and having your oncologist touch base with a prospective trial-coordinating doctor can help open the door.
Read MoreParticipating in a clinical trial can provide hope for those with ALK-positive lung cancer, offering a glimpse into the realm of cutting-edge treatments. Understanding eligibility criteria can be paramount for those seeking to participate in a clinical trial. Here we will highlight some of the opportunities and challenges of clinical trial eligibility
Read MoreI’m writing this on the return flight from the University of Michigan, where I underwent a thoracic biopsy for three lymph nodes that have been lighting up in my recent PET scans. As I am the ALK Positive patient advocate on the Judith Tam ALK NSCLC Research Initiative Scientific Advisory Board, l thought I’d do a trial run and see if going there for my biopsy and tissue testing would be worthwhile.
Read MoreOne of the challenges in our community has been the treatment of earlier stages of ALK-positive lung cancer, including stages IA through 3A. Historically, we've faced a lack of definitive guidelines for addressing the illness that represents 30-40% of the total ALK lung cancer population. Patients in these stages are traditionally treated with surgical tumor removal, followed by platinum chemotherapy. This treatment is a "one size fits all" approach to earlier stage lung cancer, without concern for the presence of the ALK mutation.
Read MoreThe spectrum of ALK-positive cancer knows no age limits. Meet the faces of courage: the ordinary individuals with the ALK-positive mutation. This mutation, notorious for lung cancer in adults, defies the stereotype. At just 52 years old, these fighters, who are usually non-smokers, shatter expectations. Yet, it doesn’t stop there – the youngest warriors, too, bear the burden of ALK-positive mutations. While a handful of kids battle ALK-positive lung cancer, an even greater number grapple with foes like lymphoma, sarcoma, and brain cancer, all stemming from the ALK-positive mutation.
Read MoreThe ALK Positive NSCLC Research Acceleration Committee (RAC) systematically reaches out to selected biotech companies with NSCLC treatments in development and/or trial. In February of 2022, RAC member Ray Hall (father to patient Summer Farmen) wrote a letter to the CEO of Memgen Inc., introducing us and asking for a get-acquainted Zoom meeting, which occurred shortly thereafter. CEO Greg Brown, MD, MBA, and Chief Scientific Officer Mark Cantwell, PhD let us know that they were initiating a clinical trial at Duke and Moffit Cancer Centers for their oncolytic virus drug MEM-288 for patients with solid tumors
Read MoreThe decision to enroll in a clinical trial requires a real understanding of what is being studied and how you will participate in the study. It is important to remember that clinical trials have been instrumental in developing all treatments for ALK-positive cancers. Many of our longest survivors have participated in clinical trials of treatments that are now the standard of care.
Read MoreWe interviewed fellow ALKie Andrej Krivda on his very interesting journey with ALK+ lung cancer and all the unexpected twists and turns he’s had to navigate since diagnosis. Andrej is the very first person to enter the Nuvalent NVL-655 clinical trial in Spain and one of the first patients to take part in the trial in all of Europe, and we were very interested in his perspective. He also happens to have a fascinating personal history. Enjoy the read!
Read MoreAt any juncture in treatment, those with ALK Positive cancers are faced with hard choices. Whether you are first starting treatment or you are changing treatment due to progression or side effects, multiple options may be available. At these critical decision points, a clinical trial could be an excellent choice. You may trust your doctor to refer you to a clinical trial, but it is nearly impossible for any doctor to be aware of all the clinical trials that are available for ALK.
Read MoreNVL-655 is a new experimental ALK inhibitor that is designed to treat ALK cancers, especially those that have become resistant to ALK inhibitors like lorlatinib, alectinib, and brigatinib. The study of this new drug is underway! Clinical trial sites in the U.S. include Orange, California; Denver, Colorado; Boston, Massachusetts; Detroit, Michigan; New York, New York; Nashville, Tennessee; and Seattle, Washington. The expansion to Europe includes sites in Toulouse Cedex, France; Villejuif, France; and Barcelona, Spain.
Read MoreHighly successful Covid vaccines have raised the question of ‘why not cancer vaccines?’, a question of great interest and financial contribution for the ALK Positive NSCLC community in recent years. Somewhat under the radar of our members is Moderna, Inc.’s multi-cancer clinical trial for their personalized mRNA vaccine that started in 2017. The trial is open to ALK NSCLC patients after progressing on TKIs, and it is based on the same platform as their approved Covid mRNA vaccine. It is currently in a multiple-arm Phase 1 trial and a randomized, fully enrolled Phase 2 trial.
Read MoreNVL-655 is a new experimental ALK inhibitor that is designed to treat ALK cancers, especially those that have become resistant to ALK inhibitors like Lorlatinib, Alectinib, and Brigatinib. This brain-penetrable drug not only addresses the typical ALK mutation, but it also targets compound mutations that tend to occur when there is tumor progression.
Read MoreImugene’s CF33, or Vaxinia, is a modified DNA virus of the Poxviridae family developed by Professor Yuman Fong at the City of Hope Comprehensive Cancer Center in Los Angeles. Vaccinia, or pox, viruses have a track record of safe use in millions of humans, as the original variant was the active constituent of the vaccine that eradicated smallpox, and first proved able to kill cancer cells in 1922. CF33 has the potential to act as both a gene therapy delivery vehicle and an oncolytic (cancer-killing) agent.
Read MoreClinical trials are studies that are done in humans to test a new treatment. Long before a clinical trial, a host of “pre-clinical” studies must test the feasibility, safety, and effectiveness of a new treatment. Preliminary work involves chemistry to develop a compound that can be manufactured and has the potential to inhibit cancer growth. That compound is then tested for safety and effectiveness.
Read MoreThe Phase 1/2 trial of Nuvalent, Inc.’s NVL-655, the fourth generation ALK TKI, has begun at Sarah Cannon Research Institute in Nashville, soon to be followed by additional locations. For patients currently on Lorlatinib, NVL-655 provides a hope-filled option for those who test positive for certain mutations that are common upon progression on Lorlatinib. The trial is also open to a range of patients described below that are progressing after other treatment options.
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